Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)

May 14, 2021 updated by: Shire

Open-label Patient Continuation of DX-88 (Ecallantide) for Acute Hereditary Angioedema Attacks

The purpose of this study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4) trial will be followed up and treated for subsequent attacks in this trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open label trial.

The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide in the treatment of acute attacks of hereditary angioedema. This study is designed to provide efficacy and safety data on repeated use of ecallantide. These data are intended to support the marketing authorization of ecallantide in the treatment of acute attacks of hereditary angioedema. Efficacy and safety of ecallantide will be evaluated in this study.

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4G2
        • Allergy and Asthma Research Centre
  • Jordan
      • Amman, Jordan, 1194
        • Jordan University Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Aaron Davis
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital
      • Little Rock, Arkansas, United States, 72205
        • Little Rock Allergy & Asthma Clinic
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Summit Comprehensive Cancer Center
      • Crescent City, California, United States, 95531
        • Pacific Coast Allergy
      • Granada Hills, California, United States, 91344
        • Jacob Offenberger
      • Los Angeles, California, United States, 90095-1680
        • UCLA David Geffen School of Medicine, Department of Medicine
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Asthma and Allergy Associates, P.C.
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Hospital, Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center, Georgetown University Hospital
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami, General Clinical Research Center
      • Tampa, Florida, United States, 33613
        • University of South Florida, Asthma, Allergy and Immunology Clinical Research Unit
      • West Palm Beach, Florida, United States, 33401
        • Roberson Allergy and Asthma
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Family Allergy & Asthma Center, PC
      • Columbus, Georgia, United States, 31904
        • Allergy Center of Brookstone
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University Consultants in Allergy and Immunology
    • Indiana
      • Muncie, Indiana, United States, 47304
        • Muncie Allergy Center
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Kansas City Allergy & Asthma
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • Institute for Asthma and Allergy
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States, 02467
        • Brigham and Women's Hospital
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Asthma and Allergy Institutes of Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Respiratory Medicine Research Institute of Michigan, PLC
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Nevada Access to Research and Education Society
      • Reno, Nevada, United States, 89503
        • University of Nevada School of Medicine
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • UMDNJ- New Jersey Medical School
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Allergy Partners of Albuquerque
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Allergy Partners of Western North Carolina
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati, Division of Internal Medicine
      • Columbus, Ohio, United States, 43235
        • Optimed Research, LLC
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Asthma Allergy and Pulmonary Associates
      • Pittsburgh, Pennsylvania, United States, 15213
        • Children's Hospital of Pittsburgh
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Highlands Allergy and Asthma Center, PC
    • Texas
      • Bryan, Texas, United States, 77802
        • The Paull Allergy and Asthma Clinic, P.A
      • Dallas, Texas, United States, 75231
        • AARA Research Center
    • Utah
      • Salt Lake City, Utah, United States, 84132-2409
        • University of Utah Health Sciences Center
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Clinical Research Associates of Tidewater
    • Washington
      • Tacoma, Washington, United States, 98405
        • Puget Sound Allergy, Asthma, & Immunology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 10 years of age or older
  • Documented diagnosis of HAE (Type I or II)
  • Willing and able to give informed consent
  • Acute HAE attack at time of presentation

Exclusion Criteria:

  • Receipt of an investigational drug or device, within 30 days prior to study treatment, other than DX-88 (ecallantide)
  • Pregnancy or breastfeeding
  • Receipt of non-investigational C1-INH or DX-88 within 72 hours of treatment
  • Patients eligible for current, ongoing clinical trial in which DX 88 (ecallantide) is offered

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DX-88 (ecallantide)
DX-88 (ecallantide) Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
Drug: ecallantide
solution for SC injection, one 30 mg dose per HAE attack
Other Names:
  • DX-88

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing
Time Frame: 4 hrs post dose after every episode
Mean Symptom Complex Severity (MSCS) score is a validated point-in-time measure of symptom severity. At baseline and 4 hrs, patients rated the severity on a categorical scale (0=normal, 1=mild, 2=moderate, 3=severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more.
4 hrs post dose after every episode

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Outcome Score (TOS) at 4 Hrs Post Dosing, Based on the Patient Assessment of Baseline Severity of Symptoms
Time Frame: 4 hrs post dose after every episode
The Treatment Outcome Score (TOS)is a validated measure of response to therapy. Response assessment for each symptom complex (internal head/neck, stomach/GI, genital/buttocks, external head/neck or cutaneous) was to be weighted based on the severity of symptom complexes at baseline. Severity assessment at baseline was rated on a categorical scale (1=mild, 2=moderate, 3=severe) for symptoms at each affected symptom complex. Response assessment of each symptom complex post-dosing relative to baseline used a scale (100=significant improvement, 50=improvement, 0=same). The weighted values were used to calculate the composite TOS. A TOS greater than 0 denotes an improvement in symptoms compared with baseline severity.
4 hrs post dose after every episode
Time to Significant Improvement
Time Frame: 15 min - 4 hrs post dose after every episode
Time to significant improvement in overall response based on the period from 15 minutes after dosing through 4 hrs post dosing. Significant improvement was defined as a response of "a lot better or resolved" in the overall response assessment.
15 min - 4 hrs post dose after every episode

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

April 4, 2007

First Submitted That Met QC Criteria

April 4, 2007

First Posted (Estimate)

April 5, 2007

Study Record Updates

Last Update Posted (Actual)

June 8, 2021

Last Update Submitted That Met QC Criteria

May 14, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DX-88/19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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